The present invention, in some embodiments thereof, relates to the field of surgically created openings for stomal discharge removal (stoma) in living subjects, and more particularly, to devices and methods for covering a stoma as may be used in the case of a colostomy, ileostomy or urostomy.
In performing an ostomy, the physician will generally form the stoma in the abdominal wall and attach an end or a side of a healthy portion of the intestine (large or small intestine, depending on the type of ostomy) to the stoma from the visceral side of the abdominal wall or, alternatively, pass the intestinal portion through the stoma and attach it to the outside of the abdominal wall. The stoma may be permanently left in a patient suffering from a condition for when it is no longer possible for the intestinal content to pass out via the anus, for example, due to colon cancer, diverticulitis, trauma, or inflammatory bowel disease; or may be temporary, as may be the case following an operation on a section of the bowel (small intestine and/or large intestine) requiring a healing period.
The use of an ostomy appliance is indicated for patients with a stoma, to help manage stomal discharge. According to the nature of the stoma, stomal discharge may comprise, for example, fecal matter, urine, and/or mucus. Appliances may be wholly external, or at least partially internal. Common elements of ostomy appliances include a pouch for collecting stomal discharge, and a means to seal the pouch over the stoma. In some cases, a plug or cover is used in addition to or in place of a pouch. Ostomy appliance designs described in the art include the following.
U.S. Pat. No. 7,250,040 relates to “an arrangement at a stoma bag of the type used by persons or animals with a colostoma, including a flexible bag (flexibag) and a ring fastener/magazine ring, where the ring fastener/magazine ring is designed to be connected to a stoma plate, and where, in its initial position, the entire flexibag is located in or in close proximity to the ring fastener/magazine ring.”
U.S. Patent Application Publication Number 2004/0181197 relates to “a flexible membrane is situated within a rigid or semi-rigid cap. The edge of the cap wall is adhesively fixed to the tissue surrounding the stoma. The interior of the cap is pressurized to press the membrane to seal the stoma against the discharge of solid and semi-solid waste. Gas escapes through a vent with a filter element. The cap can be pressurized by an external pump or an integral pump member situated on top of the cap. A relief valve prevents over pressurization. A collection pouch can be provided as part of a device. The device can be removably mounted on a standard two-piece faceplate.”
U.S. Patent Application Publication Number 2007/0088300 relates to “a single-use ostomy appliance is described including an ostomy coupling for releasable coupling first and second portions at a stomal orifice. The two portions may be separable body-side and non-body-side parts, or the two portions may be portions of a unitary ostomy device such as a controlled evacuation device. The coupling includes a mechanical fastener configured such that the coupling is rendered substantially not resecurable after the fastener is released.”
U.S. Patent Application Publication Number 2007/0191794 relates to “a controlled evacuation ostomy appliance comprises a membrane that is urged into sealing engagement with a stoma, by the generation of radial tension in the membrane. A tensioning device applies tension, with respect to the stoma, at one or more positions that are (i) outboard of the periphery of the projecting portion of the stoma, and/or (ii) between the level of the peristomal skin and the level of the most projecting part of the stoma. Tension limiting means are disclosed. The membrane may be gas-permeable to allow flatus to be vented.”
U.S. Pat. No. 6,689,111 relates to “a balloon-like member is received in the bowel and inflated to seal the stoma. The member includes a thin, flexible wall defining an opening. A rigid or semi-rigid cap retains the member and closes the opening in the member wall. Skin comfortable adhesive adheres the edge of the cap to the tissue surrounding the stoma. A flexible dilation tube facilitates insertion of the member and cooperates with a pump to inflate the member. The cap is preferably removably attached to a standard two-piece ostomy faceplate and is provided with a filter element to vent flatus.”